CAJ | 학술논문

目的评估七叶洋地黄双苷滴眼液在准分子激光原位角膜磨镶术(LASIK)后视疲劳患者中的治疗作用,评价其临床有效性和安全性.方法这是一项前瞻性的开放性、多中心、随机对照研究.上海复旦大学附属眼耳鼻喉科医院等7家医院多中心联合开展临床研究.选取2008年7月至2009年1月就诊的LASIK手术患者.采用随机数字表法将患者随机分入对照组和治疗组,对照组常规用药,治疗组在给予对照组相同治疗药物的基础上,从术后第1天开始增加使用七叶洋地黄双苷滴眼液.术后第1、第2、第4周复诊,评价指标包括主觉症状、裸眼视力、屈光度、调节幅度、调节滞后量、调节灵敏度和正/负相对调节.符合入选标准患者共195例,其中男88例,女107例,平均年龄为(25.4±5.9)岁.对照组86例,治疗组109例.对所得数据采用嵌套模型的方差分析进行统计学处理.结果对视疲劳主觉症状分析提示,LASIK术后使用七叶洋地黄双苷滴眼液可改善阅读时字体变模糊(F=4.099,P＜0.05)及近距离工作后头痛或恶心症状(F=4.344,P＜0.05).治疗组术后调节灵敏度改善较对照组明显,差异有统计学意义(左眼:F=5.895,P＜0.05;右眼:F=7.440,P＜0.05;双眼:F=5.323,P＜0.05).治疗组术后负相对调节改善较对照组明显,差异有统计学意义(F=5.561,P＜0.05).结论七叶洋地黄双苷滴眼液对LASIK术后主观不适症状、调节灵敏度、负相对调节有明显改善作用.七叶洋地黄双苷滴眼液治疗LASIK术后早期视疲劳安全、有效.
목적 평고칠협양지황쌍감적안액재준분자격광원위각막마양술(LASIK)후시피로환자중적치료작용,평개기림상유효성화안전성.방법 저시일항전첨성적개방성、다중심、수궤대조연구.상해복단대학부속안이비후과의원등7가의원다중심연합개전림상연구.선취2008년7월지2009년1월취진적LASIK수술환자.채용수궤수자표법장환자수궤분입대조조화치료조,대조조상규용약,치료조재급여대조조상동치료약물적기출상,종술후제1천개시증가사용칠협양지황쌍감적안액.술후제1、제2、제4주복진,평개지표포괄주각증상、라안시력、굴광도、조절폭도、조절체후량、조절령민도화정/부상대조절.부합입선표준환자공195례,기중남88례,녀107례,평균년령위(25.4±5.9)세.대조조86례,치료조109례.대소득수거채용감투모형적방차분석진행통계학처리.결과 대시피로주각증상분석제시,LASIK술후사용칠협양지황쌍감적안액가개선열독시자체변모호(F=4.099,P＜0.05)급근거리공작후두통혹악심증상(F=4.344,P＜0.05).치료조술후조절령민도개선교대조조명현,차이유통계학의의(좌안:F=5.895,P＜0.05;우안:F=7.440,P＜0.05;쌍안:F=5.323,P＜0.05).치료조술후부상대조절개선교대조조명현,차이유통계학의의(F=5.561,P＜0.05).결론 칠협양지황쌍감적안액대LASIK술후주관불괄증상、조절령민도、부상대조절유명현개선작용.칠협양지황쌍감적안액치료LASIK술후조기시피로안전、유효.
Objective To evaluate the clinical effect and safety of esculin and digitalisglycosides eye drops in patients with asthenopia after laser in situ keratomileusis (LASIK) surgery.Methods This was an open,multicenter,random and antithetical prospective clinical trial. Post-LASIK surgery patients were chosen from seven hospitals across China from July 2008 to January 2009.Some patients received esculin and digitalisglycosides eye drops and others served as controls. Symptoms of asthenopia,uncorrected visual acuity (UCVA),refraction,amplitude of accommodation,lag of accommodation,accommodative sensitivity and positive/negative relative accommodation were compared between the two groups at different time points.A total of 195 patients (88 males and 107 females) were included in the study with a mean age of (25.4±5.9)years.Among the 195 patients,109 were in the treatment group and 86 were in the control group.Data were analyzed using a nested ANOVA.Results Blurred vision after reading (F=4.099,P＜0.05) and headache or sickness following near work (F=4.344,P＜0.05) improved in the treatment group compared to the control group.Accommodative sensitivity (left eye:F=5.895,P＜0.05;right eye:F=7.440,P＜0.05;both eyes:F=5.323,P＜0.05) and negative relative accommodation (F=5.561,P＜0.05) were also better in the treatment group.Conclusion Esculin and digitalisglycosides eye drops can significantly alleviate the symptoms of asthenopia in patients following LASIK surgery.It can also improve the accommodative sensitivity and negative relative accommodation in post-LASIK surgery patients.